Lower Silesia Culotte Bifurcation Registry (LSCBR).
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRegional Cardiology Center, The Copper Health Centre (MCZ),
About this trial
The study aimed to evaluate the outcomes of bifurcation PCI using two techniques (Culotte vs. DK-Culotte) using data from a retrospective analysis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Presence of significant changes in the coronary bifurcation requiring the implantation of two coronary stents using the Culotte or DK Culotte technique.
Disqualifiers
Patients who underwent PCI with coronary stents prior to the index procedure for the bifurcation lesion studied.
Trial population
The study includes a retrospective analysis of subjects who underwent PCI in two cooperative cardiac centers in the Lower Silesia region between April 2012 and January 2024. Data from the participating centers on all PCIs performed during these periods were prescreened for bifurcation lesions with subsequent implantation of two stents using the Culotte technique or the DK-Culotte technique. The indication for percutaneous coronary intervention (PCI) was based on the judgment of the cardiac team or on a specific clinical indication (persistent ischemia, unwillingness to accept alternative treatment options, presence of significant angiographic CAD suitable for PCI). The decision to perform PCI with the two-stent technique was left to the operator's judgment based on clinical and angiographic characteristics.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Bifurcation PCI with two stent technique Culotte Technique or Double Kiss (DK) Culotte
Procedure/SurgeryPatient with CAD and coexisting bifurcation lesion requiring two-stent approach treated with Culotte Technique or Double Kiss (DK) Culotte due to operator distraction.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Culotte Group1 intervention
Group B: Double Kiss (DK) Culotte Group1 intervention
Trial outcomes
Primary outcomes
1
Target lesion failure (TLF)
The primary endpoint was target lesion failure (TLF): the composite of cardiac death, target vessel myocardial infarction (TVMI), or clinically driven TLR.
Time frame
Final assessment - 5 years after the initial hospitalization; followed by evaluation every 6 months from the end of the hospitalization until the final assessment (5 years)Secondary outcomes
1
MACE
The secondary composed outcome was MACE: myocardial infarction (MI), cardiac death, MB-TLR or/and SB-TLR
Time frame
Final assessment - 5 years after the initial hospitalization; followed by evaluation every 6 months from the end of the hospitalization until the final assessment (5 years)Other outcomes
1
Stent thrombosis
Stent thrombosis in a stent implanted in a bifurcation during primary intervention. Stent thrombosis was defined according to The Academic Research Consortium-2 consensus document. The presence of a thrombus† that originates in the stent/scaffold or in the segment 5 mm proximal or distal to the stent/scaffold or in a side branch originating from the stented/scaffolded segment and the presence of at least 1 of the following criteria: 1)Acute onset of ischemic symptoms at rest 2)New electrocardiographic changes suggestive of acute ischemia 3)Typical rise and fall in cardiac biomarkers (refer to definition of spontaneous myocardial infarction) or Pathological confirmation of stent/scaffold thrombosis
Time frame
Final assessment - 5 years after the initial hospitalization; followed by evaluation every 6 months from the end of the hospitalization until the final assessment (5 years)2
Stent restenosis
Stent restenosis in a stent placed in a bifurcation during primary intervention. Stent restenosis should be confirmed by either angiography or intravascular assessment.
Time frame
Final assessment - 5 years after the initial hospitalization; followed by evaluation every 6 months from the end of the hospitalization until the final assessment (5 years)Sponsors and contacts
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Regional Cardiology Center, The Copper Health Centre (MCZ),
Lead sponsor
Department of Cardiology, Provincial Specialized Hospital in Legnica, 59-200 Legnica, Poland.
Collaborator
Source ClinicalTrials.gov